Kornimate/medical-research-clean huggingface dataset:
predictive value of procalcitonin, crp, drain fluid culture, il-6 and tnf-α in anastomotic leakage

Conditions: Anastomotic Leakage in Colon Surgery

Summary: evaluating predictive value of serum procalcitonin, c-reactive protein, drain il-6 and tnf-alpha for anastomotic leakage in post-operative period.

to search for a biomarker, which might be able to predict rectal anastomotic leakage before its clinical presentation. serum procalcitonin, c-reactive protein, and drain fluid culture, il-6 and tnf-α levels were evaluated in 50 consecutive patients with rectal cancer who underwent low anterior resection with colorectal anastomosis.

Eligibility criteria:
inclusion criteria: * patient underwent to colonic resection and had drain exclusion criteria: * other patients
ultra-violet fluorescence bronchial cancer location

Conditions: Lung Cancer

Summary: diagnose lung cancer at an early stage is crucial for effective treatment. at these early stages, cancer is usually invisible in ambient white light when the endoscopic analysis of the bronchial mucosa. this lining is self-fluorescent at its illumination by blue light. these widely distributed autofluorescence methods detect early mucosal abnormalities. they are very sensitive but not specific to recognize the lung cancer. thanks to european funding (eurimus), a new tool with fluorescent uv light has been developed. the purpose of this preliminary study is to verify the suitability for specific detection of cancerous tissue in pneumology of this fluorescence method versus histological analysis of the tissue.


Eligibility criteria:
inclusion criteria: * patient affiliated or entitled to a social security scheme * major patient * patient who signed the informed consent document * patient with a known primary cancer in bronchial level exclusion criteria: * pregnant woman * patient with a benign tumor histology * patient with an unknown tumor histology.
an exploratory trial to assess the improvement of adverse events in chronic myelogenous leukemia patients treated with imatinib when switched to nilotinib treatment

Conditions: Chronic Myelogenous Leukemia

Summary: the purpose of this exploratory study will be to examine changes in chronic low grade chronic adverse events, measured by common terminology criteria for adverse events (ctcae) grading, when patients are switched from imatinib to nilotinib therapy.


Eligibility criteria:
inclusion criteria: 1. male or female patients ≥ 18 years of age 2. eastern cooperative oncology group (ecog) 0, 1, or 2 3. diagnosis of cml-cp associated with bcr-abl quantifiable by rq-pcr (is) 4. patients must be an imatinib responder and achieved the following efficacy milestones as appropriate for the length of time on imatinib therapy as per protocol 5. cml-cp patients initiated on any dose of imatinib 6. ability to provide written informed consent prior to any study related screening procedures being done exclusion criteria: 1. loss of chr or cytogenetic response 2. prior accelerated phase or blast phase cml 3. previously documented t315i mutation 4. presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than ph+. 5. previous treatment with any other tyrosine kinase inhibitor except for imatinib. 6. treatment with other investigational agents within 30 days of day 1. 7. history of non-compliance to medical regimens or inability to grant consent. 8. women who are pregnant, breast feeding, or of childbearing potential without a negative serum test at baseline. male or female patients of childbearing potential unwilling to use contraceptive precautions throughout the trial and 3 months following discontinuation of study drug. post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. women of childbearing potential must have a negative serum pregnancy test prior to the first dose of nilotinib. other protocol-defined inclusion/exclusion criteria may apply

Keywords: cml leukemia tasigna nilotinib amn107 cml-cp chronic phase
ahc ballana heart study

Conditions: Genetic Predisposition to Disease

Summary: this study is designed to assess cvd incidence, prevalence, progression and related risk factors, including genetic background. it will provide an important base for all cardiovascular research activities in our centre and help in designing future studies and guide policy.

background population-based longitudinal studies are a cornerstone in understanding current disease landscapes affecting communities and collecting reliable data to guide prevention and treatment strategies. in egypt there is pressing need of collecting reliable data on cardiovascular disease (cvd) in defined populations. objectives defining the cardiovascular phenotype, genotype as well as omics and risk factors for cvd in a defined population in egypt with follow up for up to 30 years methods as a first step, a random representative sample of 1,200 households from the ballana population will be created. following inclusion, patients will be screened for their cardiovascular profile and followed up for changes in their profile and cardiovascular events continuously every year in high risk patients and every 3 years for the rest of the participants for a period of 30 years.

Eligibility criteria:
inclusion criteria: * residents of ballana from the 1,200 randomly selected households * participants must have a valid national id card * written informed consent exclusion criteria: • residents who are younger than 18 years

Keywords: genetics cardiovascular risks
effect of a mixed macronutritional meal with medium chain triglycerides on the oxidation of postprandial macronutrients

Conditions: Metabolic Syndrome

Summary: the main aim of this study is to determine the effect of the addition of medium chain triglycerides to a mixed macro nutritional meal on postprandial macronutrients oxidation (i.e. fat oxidation, carbohydrate oxidation, change in respiratory quotient, peak respiratory quotient, etc.).

a mixed meal characterized by a high quantity of carbohydrates could develop an increment in the postprandial carbohydrate oxidation. medium chain triglycerides could be absorbed and metabolized immediately. it is plausible that its addition to a mixed meal unchains the decrement in the carbohydrate oxidation and increment in fat oxidation. if this hypothesis it is correct, its lower postprandial carbohydrate oxidation could develop a higher postprandial exposure to hyperglycemia, being of clinical interest. 20 young adults will be randomized into two conditions (experimental and control conditions) with 7 days of separation between conditions. each evaluation day will conform to the following tests: 1. basal metabolic rate assessment through indirect calorimetry. 2. intake of the corresponding mixed meal (experimental or control) 3. postprandial nutrient oxidation and energy expenditure through indirect calorimetry 4. blood samples assessment in 9 time points during the evaluation day. 5. post-prandial sensations related to appetite in 11 time points during the evaluation day

Eligibility criteria:
inclusion criteria: * healthy male or female * ages 18-30 years * bmi: 18-27.5 kg/m2 * stable weight over the last 3 months (body weight changes\<35kg) * participant must be capable and willing to provide consent, understand exclusion criteria, instructions and protocols. exclusion criteria: * history of cardiovascular disease * diabetes or hypertension * pregnant, planning to become pregnant, or breastfeeding * have been treated previously or during the study period with prescription drugs: antihypertensive, lipid lowering, acid uric lowering, glucose lowering, beta blockers or any drug that under the investigator's judged could influence the results. * hematological pathology * have had a blood transfusion or severe blood loss within the last 3 months * allergy/intolerance to milk proteins, fish, soy, and/or any ingredient of the mixed meal * any non-controlled medical condition which could influence results or could be worsened by the participation in the study * claustrophobia * needle phobia * are deemed unsuitable by the investigator for any other reason, that prevent data collection.
effects of seroquel xr on sleep architecture in patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: in this study, patients with major depressive disorder (mdd) who have insomnia symptom are treated with seroquel xr in an open-label manner for a 4-week period with repeated measurements of insomnia symptoms and sleep parameters using polysomnography.


Eligibility criteria:
patient inclusion criteria: * men and women aged between 20 and 65 * diagnosis of major depressive disorder as assessed by structured clinical interview for dsm-iv (scid-iv) * a score of 1 or greater on any of the sleep items (items 4, 5, 6) from the hamilton depression rating scale (hdrs) * provision of written informed consent healthy control subject inclusion criteria: * healthy men and women aged between 20 and 65 * provision of written informed consent exclusion criteria: * presence of any major physical or neurological illness (e.g.，head trauma， epilepsy，seizure，stroke，cerebral tumor，multiple sclerosis，cerebrovascular disease, narrow-angle glaucoma, drug hypersensitivity，etc.) * diagnosis of any axis i disorder other than major depressive disorder or presence of symptoms requiring hospitalization * drug abuse in past 3 months * women who are pregnant，breastfeeding, or planning pregnancy * contraindications to drugs used in the study (e.g., allergy, intolerance, etc.) * unstable medical illness or severe abnormality in laboratory test at screening assessment * increase in blood glucose, lipid, and calcium levels at screening * low blood pressure at screening assessment * intelligence quotient below 80 * use of any of the following cytochrome p450 3a4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir * use of any of the following cytochrome p450 3a4 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, st. john's wort, and glucocorticoids * administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation * substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by dsm-iv criteria * opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by dsm-iv criteria within 3 months prior to enrolment * previous enrolment or randomisation of treatment in the present study. * participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements * medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment * a patient with diabetes mellitus * an absolute neutrophil count (anc) of \<= 1.5 x 10\^9 per liter * insomnia from other causes of medical or neurological diseases * involvement in the planning and conduct of the study
french digestive polyposis cohorte family adenomatous polyposis with apc and myh gene mutations , cowden's disease with pten gene mutation, peutz jeghers disease with stk 11 gene mutation ,juvénil polyposis with smad 4 gene mutation , serrated and hyperplastic polyposis

Conditions: Quality of Life

Summary: french cohorte about polyposis digestive diseases

family adenomatous polyposis apc and myh genes peutz jeghers disease cowden disease festooned polyposis juvenile polyposis hyperplastic polyposis

Eligibility criteria:
inclusion criteria: * apc gene mutation * myh homozygote mutation * cowden disease with pten gene mutation * peutz jeghers disease with stk 11 gene mutation * juvenile polyposis with smad 4 gene mutation exclusion criteria: * heterozygote myh gene mutation
efficacy and safety study of ingavirin® to treat influenza and other acute respiratory viral infections in patients 3-6 y.o.

Conditions: Common Cold; Influenza

Summary: the purpose of this study is to determine whether ingavirin ® dosed 30 mg daily is effective and safe in the treatment of influenza and other acute respiratory viral infections in the course of standard therapy in 3-6 years old patients.


Eligibility criteria:
inclusion criteria: * the informed consent form signed by the patient's parent/adoptive parent to participate in the clinical study. * male and female patients aged 3-6. * patients with moderate course of influenza or other acute respiratory viral infections. * patients with clinically diagnosed influenza or other arvi based on the body temperature \> 37,5 ° c, not less than 1 of the following other symptoms of intoxication and not less than 1 of the following of catarrhal symptoms: * intoxication symptoms: headache, malaise, myalgia, pain in the eyeballs; * catarrhal symptoms: sore throat, rhinorrhea, cough, nasal congestion. * established diagnosis j06.9, j10, j11, in accordance with icd-10. * uncomplicated course of influenza and other arvi. * interval between onset of symptoms and enrollment to the study of not more than 36 hours. exclusion criteria: * complicated course of influenza and other acute respiratory viral infections. * treatment with antiviral drugs (antivirals, interferons and interferon inducers), drugs with immunomodulatory effects or antibiotics with systemic and local action within 14 days prior to the screening visit. * severe influenza or other arvi with symptoms of cardiovascular disease, and other symptoms of infectious-toxic shock, and meningoencephalitic syndromes. * signs of primary viral pneumonia development (presence of two or more of the following symptoms): shortness of breath, chest pain when coughing, systemic cyanosis, dullness of percussion sound at symmetrical assessment of the upper and lower parts of the lungs. * infectious diseases within the last week prior to enrollment. * "rri children" (incidence of arvi within the last 12 months is 6 times or more). * asthma history. * history of increased seizure activity. * severe decompensated or unstable medical or psychiatric conditions (any diseases or conditions that threaten the life of the patient or worsen the patient's prognosis and also make it impossible to conduct a clinical study in the patient). * cancer, hiv infection, tuberculosis, including those in history. * hypersensitivity to imidazolyl ethanamide pentandioic acid and/or excipients of ingavirin product. * diabetes, lactose intolerance, lactase deficiency, glucose-galactose malabsorption, deficiency of sucrase/isomaltase, fructose intolerance, hereditary glucose malabsorption, deficiency of glucose-6-phosphate dehydrogenase. * participation of the patient in any other clinical trial within the last 90 days prior to enrollment.

Keywords: ingavirin common cold influenza acute respiratory viral infections pediatric clinical trial imidazolyl ethanamide pentandioic acid
the effect of sildenafil in preterm infants with evolving chronic lung disease

Conditions: Lung Diseases

Summary: the purpose of this pilot study is to investigate in a randomised double-blind trial whether treatment with sildenafil reduces duration of ventilatory support in preterm infants born at 28 weeks of gestation or less.


Eligibility criteria:
inclusion criteria: * newborn babies born \<28 weeks of gestation who still need ventilatory support via endotracheal tube or have been re-ventilated at day 7 of life. exclusion criteria: * congenital heart defects * suspected inborn error of metabolism * inhaled nitric oxide treatment during assessment
vancomycin and fecal microbiota transplant in a single patient with autism spectrum disorder

Conditions: Autism Spectrum Disorder; Autism

Summary: single patient with asd will be treated with vancomycin followed by fmt.

a single patient with profound asd will be treated with vancomycin. this will be followed by fecal microbiota transplant. the patient will be followed for one year.

Eligibility criteria:
inclusion criteria: 1. diagnosis of autism spectrum disorder 2. parent or legally authorized representative willing and able to provide informed consent 3. a reliable caregiver who can report side effects and communicate effectively with the research team 4. stable medications in the two months prior to enrollment 5. currently receiving interventions in the community/school for asd 6. if female and of childbearing potential, must be willing to utilize at least one highly effective method of birth control for the duration of the study. this includes condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. subjects not of reproductive potential will be exempt (e.g. post-menopausal, surgically sterilized) 7. if male, and partner is of childbearing potential, must be willing to utilize at least one highly effective method of birth control for the duration of the study. this includes condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. subjects not of reproductive potential will be exempt (surgically sterilized) exclusion criteria: 1. female subjects who are pregnant, nursing, or intend to become pregnant during the study period. 2. subjects whose caregivers are unable/unwilling to cooperate with the protocol requirements. 3. subject will be excluded who are suffering with rett syndrome and childhood disintegrative disorder. 4. other serious co-morbid medical disorders affecting brain function and behaviour, including uncontrolled seizures. 5. subjects unable to refrain from taking non-study antibiotics for the period of the study. 6. subjects diagnosed with cancer, except small localized basal cell carcinoma. 7. subjects known to abuse alcohol or drugs. 8. subjects who have undergone gastric bypass or total colectomy, or who are scheduled for these procedures. 9. infection with hiv. 10. infection with hepatitis b or c. 11. allergy to benzodiazepine. 12. inability to stop loperamide, diphenoxylate/atropine, or cholestyramine before the study 13. unable to stop opiate treatment unless on a stable dose including prn dosing, and no dose increase planned for the duration of the study 14. known positive stool cultures for enteropathogens including, but not limited to shigella, salmonella, and campylobacter within 30 days before enrollment. 15. known stool studies positive for ova and/or parasites in 30 days prior to enrollment. 16. planned travel outside united states during study period. 17. hypersensitivity to vancomycin 18. renal insufficiency 19. colitis

Keywords: fecal transplant
artificial intelligence for screening of multiple corneal diseases

Conditions: Deep Learning; Corneal Disease; Screening

Summary: this study developed a deep learning algorithm based on anterior segment images and prospectively validated its ability to identify corneal diseases.the effectiveness and accuracy of this algorithm was evaluated by sensitivity, specificity, positive predictive value, negative predictive value, and area under curve.


Eligibility criteria:
inclusion criteria: 1. the quality of slit-lamp images should clinical acceptable. 2. more than 90% of the slit-lamp image area including three main regions (sclera, pupil, and lens) are easy to read and discriminate. exclusion criteria: 1）insufficient information for diagnosis.
persistent pain after breast cancer treatment with docetaxel

Conditions: Breast Neoplasms; Pain, Postoperative; Neuralgia; Lymphedema

Summary: breast cancer treatment is for many patients followed by sequelae, such as persistent pain, sensory disturbances, lymphedema and reduced physical function. these undesired consequences of the treatment are a major clinical problem, with persistent pain affecting 25-60%, sensory disturbances 20-80%, lymphedema 2-86% and reduced physical function 13-28% of patients. development of persistent pain after breast cancer treatment, involves a complex pathophysiology that involves pre-, intra- and postoperative factors. several risk factors for the development of persistent pain after breast cancer treatment have been identified; young age, psychosocial factors, surgical procedure and radiation therapy. neurotoxicity is a well know attribute of many chemotherapeutic agents, such as taxanes. the purpose of this nationwide study is to retrospectively examine a cohort of breast cancer patients treated with docetaxel, to clarify if docetaxel may influence the prevalence and intensity of persistent pain and other sequelae.


Eligibility criteria:
inclusion criteria: * treated for primary breast cancer in denmark 2007-2008 * age between 18-80 years * no recurrent cancer * female exclusion criteria: * previous breast surgery same side (including plastic and reconstructive surgery) * bilateral breast surgery * recurrent cancer or metastatic cancer

Keywords: persistent postsurgical pain breast cancer postmastectomy pain syndrome neuropathic pain
a study of herceptin (trastuzumab) in combination with xeloda (capecitabine) in patients with metastatic or recurrent her2-positive breast cancer after first-line or (neo)adjuvant therapy.

Conditions: Breast Cancer

Summary: this single arm. open-label study will assess the efficacy and safety of herceptin (trastuzumab) in combination with xeloda (capecitabine) in patients with metastatic or recurrent her2-positive breast cancer, refractory to or relapsing after chemotherapy with herceptin and taxanes. patients will receive xeloda 900mg/m2 twice daily orally on days 1-14 of each 3-week cycle and herceptin 8mg/kg intravenously (iv) on day 1 of the first cycle followed by 6mg/kg iv every 3 weeks. the anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility criteria:
inclusion criteria: * female patients, 18-65 years of age * histologically confirmed her2-positive breast cancer with measurable lesions (according to recist criteria) * metastatic disease after first-line therapy or recurrent disease after (neo)adjuvant therapy with herceptin and taxanes * ecog performance status 0-2 exclusion criteria: * cns metastases which are not well controlled * simultaneous treatment with sorivudine * history of another malignancy within the last 5 years except for cured basal cell carcinoma of the skin and cured carcinoma in-situ of the uterine cervix * pregnant or lactating women